Cognitive Effects of Minocycline in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rapid Visual information Processing
研究概览
简要总结
To determine minocycline's effects on cognitive performance and measures of mood in abstinent cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric oxide (NO) production. Previous animal and human studies suggest that minocycline may have utility as a treatment for cocaine addiction.
详细描述
We are proposing a randomized, double-blind, crossover study. A total of 40 male and or female subject completers will have two 4-day treatment periods, in which they will be randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment period, subjects will have daily clinic visits for medication administration and monitoring of adverse events. On Day 4, subjects will have an experimental session in which measures of mood and cognitive performance will be obtained. Following a washout period, ranging from 5 to 15 days, subjects will be crossed over to the alternative treatment.
This study began July 2013; currently 7 subjects were randomized with 5 completers and two drop outs. This study is in data analysis phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females, between the ages of 21 and 50 who fulfill criteria for past cocaine dependence according to DSM-IV criteria;
- •No cocaine use for the past 30 days;
- •No other current dependence or abuse of other drugs of abuse or alcohol (except cocaine and tobacco);
- •No current medical problems and normal ECG;
- •For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.
排除标准
- •current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
- •history of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
- •Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
- •Liver function tests (ALT or AST) greater than 3 times normal.
- •Allergy to minocycline or other tetracyclines.
研究组 & 干预措施
sugar pill
0.0mg
干预措施: Minocycline (Drug)
Minocycline
200mg
干预措施: Sugar pill (Drug)
结局指标
主要结局
Rapid Visual information Processing
时间窗: 2 yrs
Cognitive Test to determine the speed of Visual information
次要结局
未报告次要终点
研究者
Mehmet Sofuoglu
Mehmet Sofuoglu, M.D.,Ph.D.
Yale University